Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Dasatinib in patients with Acute Lymphoid Leukemia.
The European Medicines Agency (EMA) has authorized dasatinib (anhydrous) for the treatment of pediatric patients with newly diagnosed Philadelphia acute lymphoblastic leukemia (ALL) in combination with chemotherapy. The product information for this indication further states that his indication is based on a multicenter, historically-controlled phase 2 study that followed the chemotherapy regime detailed in another clinical trial, AIEOP-BFM ALL 2000 (chemotherapeutic standard multi-agent chemotherapy protocol).
This statement is based on a regulatory approval from the European Medicines Agency:
SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.